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NCT Number: NCT06241183

Famotidine and Antacids for Treatment of Dyspepsia

The aim of this study is to compare intravenous famotidine, an H2 receptor antagonist, and Maalox/ Mylanta, an oral antacid, in treatment of dyspepsia in the emergency department. The goal of this study is to reduce patients' pain based on the verbal numerical pain scale. The anticipated outcome is for pain levels in both groups to decrease. It is expected that antacids will improve symptoms more quickly and to a greater degree within an hour of taking medication based on the results of similar studies.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location status: Recruiting

Location contact

Adam Singer, MD

PRINCIPAL_INVESTIGATOR

Andrea Gowie

CONTACT

About this study

This study will be conducted in the Emergency Department at Stony Brook University Hospital. Investigators intend to enroll approximately 80 patients who present to the emergency department with dyspepsia symptoms. The patients will be randomized to one of two groups: one group will receive 20 mg of intravenous famotidine and the other will receive 30 ml of oral Maalox/ Mylanta. The verbal numeric pain score (VNP) will be used to measure pain at 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after administration of the study drug. Pain severity assessments will be performed by an investigator blinded to study treatment. Data will also be collected regarding demographic, clinical information, patient satisfaction and the need for rescue medications in each of the two study groups at the end of the 60-minute study period. At the end of the study period, the patients may be treated with additional analgesia at the discretion of their ED provider.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject Age ≥ 18 years of age
  • Patient diagnosed with dyspepsia
  • Present at the ED with upper abdominal pain score of at least 3

Exclusion criteria

  • Hypersensitivity to an ingredient in Maalox/ Mylanta or Famotidine
  • Moderate to Severe Renal Insufficiency (precaution)
  • Kidney Failure
  • Pregnant or Nursing
  • Verbal pain score less than 3
  • Inability to tolerate oral medications
  • Bowel Obstruction
  • Proton pump inhibitor within 2 hours of study treatment

Treatment and study plan

Intravenous Famotidine

Drug

Patients in this group will receive 20mg IV Famotidine.

Other names: H2 Receptor Antagonist

Oral Maalox/ Mylanta

Drug

Patients in this group will receive 30 ml Maalox/ Mylanta.

Other names: Antacid

Primary outcomes

  1. Verbal Numerical Pain Score

    Time frame: at 1 hour

    Patients will be asked to rate their pain on a scale of 0 to 10 with 0 indicating no pain and 10 indicating the worst pain imaginable every 15 minutes for 60 minutes.

Secondary outcomes

  1. Need for Rescue Medications

    Time frame: at 1 hour

    Investigators will assess frequency of need for rescue medications between groups.

  2. Satisfaction with Assigned Medication

    Time frame: at 1 hour

    Investigators will gather data regarding patient satisfaction with their assigned treatment using a 5 item likert scale from very dissatisfied (1), dissatisfied (2) neither satisfied nor dissatisfied (3), satisfied (4) and very satisfied (5). The outcome will be measured as the percentages of patients choosing very satisfied or satisfied with their assigned medications.

Study contacts

Contact information is provided by the study sponsor or research team.

Adam Singer, MD

CONTACT

[email protected]

6314447857

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Official study title

Comparing Intravenous Famotidine and Oral Antacids in the Treatment of Dyspepsia in the Emergency Department

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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